Universal introducer

ABSTRACT

A device for introducing a catheter into a vessel through a puncture in a vessel and for sealing the puncture. The device includes an elongated body having a proximal end and a distal end sized to be positioned within a tissue site which includes the puncture. The elongated body includes a utility lumen sized to allow a catheter to be delivered through the utility lumen. The utility lumen is positioned within the elongated body so positioning the elongated body within the tissue site allows a catheter delivered through the utility lumen to enter the vessel. The elongated body also includes a closure lumen having an entrance port. A closure composition can be delivered through the entrance port into the closure lumen. The closure lumen also includes an exit port adjacent the distal end of the elongated body. The closure composition delivered into the closure lumen can be delivered through the exit port to the tissue site adjacent the puncture.

RELATED APPLICATIONS

This application is a divisional of co-pending U.S. application Ser. No.10/795,955, filed Mar. 8, 2004, which is a divisional of U.S.application Ser. No. 09/037,659, filed Mar. 10, 1998, now U.S. Pat. No.6,733,515, which claims the benefit of Provisional U.S. Application Ser.No. 60/036,299, filed Mar. 12, 1997, entitled “Universal Introducer”,and which is a continuation-in-part of U.S. application Ser. No.08/963,408, filed Nov. 3, 1997, entitled “Vascular Sealing Device withMicrowave Antenna,” now U.S. Pat. No. 6,033,401, all of which areincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to a wound closure device, and more particularlyto a device for delivering a catheter to a vessel within a tissue siteand closing a wound caused by the catheter delivery.

BACKGROUND OF THE INVENTION

A wide variety of surgical procedures are performed by introducing acatheter into a vessel. After the surgical procedure is completed,closure of the vessel at the site where the catheter was introduced isneeded. Vessel punctures formed in the process of performing a catheterbased surgical procedure are commonly 1.5 mm to 7.0 mm in diameter andcan be larger. Closure of these punctures is frequently complicated byanticoagulation medicine given to the patient which interferes with thebody's natural clotting abilities.

Closure of a vessel puncture has traditionally been performed byapplying pressure to the vessel adjacent the puncture site. Thisprocedure requires the continuous attention of at least one medicalstaff member to apply pressure to the vessel puncture site and can takeas long as 30 minutes.

Devices have been developed for effecting the closure of vesselpunctures through the application of energy. See U.S. Pat. Nos.5,626,601; 5,507,744; 5,415,657; and 5,002,051. Devices have also beendeveloped for effecting the closure of vessel punctures through thedelivery of a mechanical mechanism which mechanically seals thepuncture. See U.S. Pat. Nos.: 5,441,520; 5,441,517; 5,306,254;5,282,827; and 5,222,974. Devices have also been developed for effectingthe closure of vessel punctures through the delivery of a composition toblock the vessel puncture. See U.S. Pat. Nos. 5,601,602; 5,591,205;5,441,517; 5,292,332; 5,275,616; 5,192,300; and 5,156,613. Despite thevarious devices that have been developed for closing vessel punctures, aneed still exists for a single device which can be used for bothintroducing a catheter into a vessel and for closing the resultingwound.

SUMMARY OF THE INVENTION

The invention relates to a device for introducing a catheter through apuncture in a vessel and for sealing the puncture. The device includesan elongated body having a proximal end and a distal end sized to bepositioned within a tissue site which includes the puncture. Theelongated body includes a utility lumen sized to allow delivery of acatheter through the utility lumen. The utility lumen is positionedwithin the elongated body so positioning the elongated body within thetissue site allows a catheter delivered through the utility-lumen toenter the vessel. The elongated body also includes a closure lumenhaving an entrance port. A closure composition can be delivered throughthe entrance port into the closure lumen. The closure lumen alsoincludes an exit port adjacent the distal end of the elongated body. Theclosure composition delivered into the closure lumen can be deliveredthrough the exit port to the tissue site adjacent the puncture.

The invention also relates to a device for introducing a catheterthrough a puncture in a vessel and for sealing tissues adjacent thepuncture. The device includes an elongated body having a proximal endand a distal end sized to be positioned within a tissue site whichincludes the puncture. A membrane is included at an outer surface of theelongated body. The membrane is positioned on the elongated body so themembrane is adjacent a portion of the tissue adjacent the puncture whenthe elongated body is positioned within the tissue site. The membrane issufficiently porous to allow a closure composition to pass through themembrane. The closure composition can be delivered into the closurelumen through an entrance port. The closure composition can be deliveredfrom the closure lumen to the membrane through at least one exit port.

The invention also relates to a system for introducing a catheterthrough a puncture within a vessel and sealing the puncture. The deviceincludes an elongated body having a proximal end and a distal end sizedto be positioned within a tissue site which includes the puncture. Theelongated body includes a utility lumen within the elongated body. Theutility lumen is sized to allow delivery of a catheter through theutility lumen. The utility lumen is positioned within the elongated bodyso when the elongated body is positioned within the tissue site acatheter delivered through the utility lumen can enter the vessel. Afirst closure lumen is coupled with the utility lumen. A closurecomposition can be delivered into the first closure lumen through anentrance port. The closure composition can be delivered from the firstclosure lumen to the utility lumen through an exit port. The system alsoincludes an obturator with a structure which allows the obturator to beat least partially positioned in the utility lumen. Positioning theobturator within the utility lumen causes a second closure lumen to beformed. The second closure lumen is at least partially defined by theobturator and the utility lumen. The second closure lumen receives theclosure composition delivered from the first closure lumen to theutility lumen and is configured to deliver the received closure compoundto the tissue site.

The invention also relates to a system for introducing a catheterthrough a puncture within a vessel and for sealing the puncture. Thesystem includes an elongated body having a proximal end and a distal endsized to be positioned at a tissue site which includes the puncture. Theelongated body includes a utility, lumen and a closure lumen throughwhich a closure composition can be delivered to tissue at the tissuesite. The system also includes a catheter guide obturator configured tobe positioned within the utility lumen of the elongated body. Thecatheter guide obturator includes a utility lumen. The utility lumen issized to permit delivery of a catheter through the utility lumen. Theutility lumen has a geometry which permits a catheter delivered throughthe utility lumen to enter the vessel when the catheter guide obturatoris positioned within the utility lumen of the elongated body which ispositioned at the tissue site.

The invention also relates to a system for introducing a catheterthrough a puncture within a vessel and for sealing the puncture. Thesystem includes an elongated body having a proximal end and a distal endsized to be positioned at a tissue site which includes the puncture. Theelongated body includes a utility lumen and a closure lumen throughwhich a closure composition can be delivered to tissue at the tissuesite. The invention also includes a trocar configured to be positionedwithin the utility lumen, the trocar includes a sharpened tip configuredto puncture the tissue making up the tissue site.

The invention also relates to a system for introducing a catheterthrough a puncture within a vessel and for sealing the puncture. Thesystem includes an elongated body having a proximal end and a distal endsized to be positioned at a tissue site which includes the puncture. Theelongated body includes a utility lumen and a closure lumen throughwhich a closure composition can be delivered to tissue at the tissuesite. The system also includes a sealing mold configured to bepositioned within the utility lumen. The sealing mold has a structurewhich causes a cavity to be formed at the distal end of the elongatedbody when the sealing mold is positioned within the utility lumen.Closure composition delivered through the closure lumen is deliveredinto the cavity.

The invention also relates to a method for introducing a catheterthrough a puncture within a vessel and for sealing the puncture. Themethod is initiated by providing a device with an elongated bodyconfigured to be positioned within a tissue site. The body includes autility lumen sized to accommodate a catheter and at least one closurelumen. A closure composition can be delivered through the closure lumen.The method concludes by positioning the elongated body within the tissuesite; delivering a catheter through the utility lumen into the vessel;performing a treatment with the catheter; withdrawing the catheterthrough the utility lumen; and delivering a closure composition throughthe closure lumen to the puncture.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A is a cross section of a closure device including a closure lumenand a utility lumen.

FIG. 1B is a sideview of a closure device according to the presentinvention.

FIG. 2 is a cross section of a closure device including sensors andenergy delivery devices.

FIG. 3 is a cross section of a closure device positioned in a tissuesite. The closure device includes a catheter delivered through a utilitylumen to a vessel in the tissue site.

FIG. 4 is a cross section of the closure device of FIG. 3 after thecatheter has been removed from the utility lumen.

FIG. 5 illustrates the closure of the hole in the vessel achieved bydelivering a closure composition adjacent the distal end in combinationwith the delivery of energy.

FIG. 6 illustrates the closure device and the vessel after the partialremoval of the closure device from the tissue site.

FIG. 7A is a sideview of a closure device with a saddle shaped distalend.

FIG. 7B is a sideview of a closure device with a saddle shaped distalend.

FIG. 7C is a perspective view of the closure device shown in FIG. 7B,illustrating the distal tip in a retracted position.

FIG. 7D is a perpective view of the closure device shown in FIG. 7B,illustrating the distal tip in a deployed position.

FIG. 8A is a sideview of a pigtail according to the present invention.

FIG. 8B is a topview of a pigtail according to the present invention.

FIG. 9A illustrates a cross section of a closure device including autility lumen with threads on an inside of the utility lumen. A pigtailwithin the utility lumen includes a head resting on the threads.

FIG. 9B illustrates a cross section of a closure device with ascrewdriver engaging the head section of a pigtail.

FIG. 9C is a cross section of a pigtail installed within a closuredevice.

FIG. 10 is a sideview of a closure device with energy and closurecomposition delivered to tissue adjacent the sides of the closure deviceas the closure device is retracted from the tissue.

FIG. 11 is a sideview of a tissue site after partial retraction of theclosure device.

FIGS. 12A is a cross section of a closure device with a solid orsemisolid closure composition present at the distal end of the closuredevice to facilitate the closure of the vessel.

FIG. 12B illustrates the closure device of FIG. 12A with the pigtailretracted.

FIG. 13 is a cross section of a closure device with a trocar in placewithin a utility lumen.

FIG. 14 is a cross section of the closure device of FIG. 13 after thetrocar has penetrated the vessel.

FIG. 15 is a cross section of a closure device with a catheter guideobturator in place within a utility lumen.

FIG. 16 is a cross section of a closure device with a sealing mold andcuring pin in place within a utility lumen.

FIG. 17 is a cross section of a distal portion of a closure device.

FIG. 18 is a sideview of a flapper valve.

FIG. 19 is a sideview of a closure device including an automaticretraction device.

FIG. 20 illustrates a closure device held within a tissue site bysutures.

FIG. 21 illustrates a closure device in place within a tissue site. Theclosure device includes a catheter delivered through a utility lumen toa vessel in the tissue site.

FIG. 22 illustrates the closure device of FIG. 21 being withdrawn fromtissue.

FIG. 23A is a longitudinal cross section of a distal end of a closuredevice.

FIG. 23B is a cross section of a proximal end of a closure device foruse with an obturator.

FIG. 23C is a vertical cross-section of a distal end of a closuredevice.

FIG. 24A is a cross section of an obturator for use with the closuredevice illustrated in FIG. 23A.

FIG. 24B is a side view of an obturator for use with the embodimentillustrated in FIG. 23A.

FIG. 25A is a cross section of the obturator of FIG. 24A installed inthe utility lumen of the closure device of FIG. 23A.

FIG. 25B is a cross section of the obturator of FIG. 24A installedwithin the closure device of FIG. 23A and withdrawn though the centrallumen until a catch on the obturator engages a catch channel on theclosure device.

FIG. 26 is a sideview of a hollow needle penetrating a vessel.

FIG. 27A is sideview of a guidewire threaded through the hollow needleof FIG. 26.

FIG. 27B illustrates the needle withdrawn from the tissue site along,the guidewire.

FIG. 28 is a cross section of a closure device. A hollow dilator isinstalled within the utility lumen of the closure device.

FIG. 29 is a cross section of the dilator and closure device of FIG. 28threaded over a guidewire and advanced through a tissue site to puncturea vessel.

FIG. 30 is a cross section of the closure device of FIG. 29 withdrawnfrom the puncture so the distal end is adjacent the puncture outside thevessel.

FIG. 31 is a cross section of an obturator installed within the utilitylumen of the closure device of FIG. 30.

FIG. 32 illustrates a closure composition source coupled with theclosure device of FIG. 31.

FIG. 33 illustrates closure composition delivered through a closurelumen to a puncture.

FIG. 34 is a cross section of a tissue site after closure compositionhas been introduced to the puncture and a closure device has beencompletely withdrawn from the tissue site.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention relates to a device and method for introducing acatheter into a vessel which is positioned within a tissue site. Anembodiment of the device includes a body with a proximal end and adistal end which is designed to be positioned adjacent a puncture in thevessel. The body includes a utility lumen configured so a catheter canbe delivered through the utility lumen and the puncture into the vessel.The body can also include a closure lumen which can be coupled with asource of fluent closure composition. The closure composition can bedelivered through the closure lumen to the puncture.

The invention can also relate to a method for using the device. Thedevice is positioned within a tissue site so the distal end of thedevice is adjacent a puncture in a vessel. A catheter is passed throughthe utility lumen and into the vessel so a surgical procedure can beperformed using the catheter. The catheter is withdrawn and a closurecomposition source is coupled with the closure lumen. The closurecomposition is delivered from the closure composition source through theclosure lumen to the puncture where it serves to bind and seal thepuncture. Since the device can be used for delivery of the catheter andsealing the puncture, there is no need to switch devices in the tissuesite. As a result, one advantage of the present invention is a deviceand method which reduces the number of necessary instruments andaccordingly the opportunity for infection.

The device can include an energy delivery device at the distal end ofthe body. The energy delivery device can deliver energy to the tissuesite and closure composition which has been delivered to the puncture.The energy can serve to increase the polymerization/cure rate of theclosure composition. Additionally, application of energy to the tissuecan promote coagulation and the natural healing processes of the tissueswithin the tissue site. The combination of these factors can increasethe rate the puncture is sealed. As a result, the device can be used toeffect quick closure of a vessel puncture.

The device can include a microporous membrane around the outside of thebody. A closure composition source can be coupled with a second closurelumen which opens to the microporous membrane. The closure compositioncan be delivered through the second closure lumen and through themicroporous membrane. The microporous membrane provides resistance tothe passage of the closure composition and can cause the closurecomposition to spread out over the microporous membrane. As a result,the closure composition contacts at least a portion of the tissuesadjacent the puncture. Withdrawal of the device allows these tissues tocontact one another and be bound together by the closure composition. Asa result, an embodiment of the device can close the tissues adjacent thepuncture.

The device can also include energy delivery devices positioned at thesides of the body. When closure composition is delivered through amicroporous membrane closure composition will be delivered to tissuesadjacent the puncture. The side electrodes can deliver energy to closurecomposition which has been delivered to these tissues. The energy canincreases the polymerization/cure rate of the delivered closurecomposition. As a result, an embodiment of the device can promote rapidclosure of tissues adjacent the puncture.

The device can also include temperature sensors positioned along thebody. The temperature sensors can detect the temperature of the tissuesadjacent to the puncture. The signal from the temperature sensors can befed to a control unit. The control unit can include logic which controlsthe flow of energy from the electrode in response to the temperature ofthe tissue. For instance, the flow of energy from the electrodes can bereduced when the temperature of the tissue becomes excessively elevated.As a result, an embodiment of the device can be used to reduce damage totissues within the tissue site.

FIG. 1A illustrates a device according to the present invention. Thedevice may be used to introduce a catheter into a vessel through apuncture in the vessel. The device can also be used to seal the punctureand close the tissues adjacent the puncture. It should be noted that thefunctioning of the device to close a puncture in a vessel and to closethe tissues adjacent the puncture are intended to be two separatefunctionalities of the device which may both be incorporated into thedevice. Alternatively, each function may be independently incorporatedinto a single device of the present invention.

The device includes a body 10 for positioning within tissue. The body 10has lateral sides 12 which terminate in a distal end 14. The body 10includes a utility lumen 16 through which a catheter (not shown) may beintroduced at a proximal end of the device 18 and out through the distalend 14 of the device. Included adjacent the distal end 14 of the utilitylumen 16 is a backflow valve 20 which reduces blood flow from the vesselthrough the utility lumen 16.

Positioned within utility lumen 16 is a pigtail 22 which is movablewithin the utility lumen 16. The pigtail 22 can pass through the devicedistal end 14 upon deployment and into the vessel (not shown).

The body 10 of the device also includes a closure lumen 24 for theintroduction of a closure composition. The device may be connected to aclosure composition source 25 by a closure composition port 26 coupledwith the closure lumen 24. The closure composition port 26 isillustrated as having an internal taper 28 of a configuration to accepta luer type fluid fitting. The distal end 14 can include a reservoir 30.The closure composition can pass from the closure composition sourcethrough the closure lumen 24 into the reservoir 30.

The device can also include an electrode 32 adjacent the distal end 14as well as side electrodes 32 adjacent the lateral sides 12 of thedevice. The device can optionally include an ultrasound transducer 34adjacent the distal end 14 of the device. In addition, the device caninclude temperature sensors 36 as well as blood pressure sensors 38. Thedevice includes a controls attachment port 40 in energy communicationwith the distal and lateral electrodes or the transducer. Similarly, theelectrical attachment port can be in communication with any sensorsincluded on the device. As a result, an energy source 42 and devicecontrol unit 44 can be coupled with the device through the controlsattachment port 40. The energy source 42 can communicate energy to theelectrodes. Optionally, the control unit can include logic whichcontrols the amount of energy delivered from the energy source 42 inresponse to the signal provided from the sensors.

The electrodes can have several configurations including, but notlimited to, ring electrodes encircling the body of the device (FIG. 1B)or positioned at the distal end of the device (FIG. 1B), electrodeswhich run the length of the body or electrodes which act as pointsources distributed about the body of the device.

The device can include a baseplate 46 including a hole 48 through whichthe device may be passed. The body of the device is movable axiallyalong the baseplate 46. The adjustability provided by the movablebaseplate is useful for accommodating variations in the length of devicethat is required to reach the artery as is dictated by the variations inhuman anatomy.

The baseplate 46 can also includes openings 50. Sutures 52 can be placedthrough the openings 50 to attach the baseplate 46 to the skin of atissue site. Attaching the baseplate to the skin can stabilize and fixthe baseplate in the position selected by the physician.

Other acceptable methods of attaching the baseplate 46 may include useof certain adhesives, particularly pressure sensitive materials.

FIG. 2 illustrates a device which may be used to effect the closure of awound in a tissue site. The device includes a body 10 with a distal end14. Lining the lateral sides 12 of the device is a microporous membrane54 having a pore size of about 1-5,000 μm through which sealing mediacan be transmitted. The device includes electrodes 32 and sensors 36.The electrodes 32 and sensors 36 can be positioned between the membraneand the body or over the membrane 54.

The body 10 includes a second closure lumen 56 coupled to a secondclosure composition port 58. The second closure composition port 58 canbe coupled to a source (not shown) for a second closure composition. Thesecond closure lumen 56 includes a plurality of channels 60 which permitthe second closure composition to pass from the second closure lumen 56to the microporous membrane 54.

FIGS. 3-6 illustrate a method of using the device of FIG. 1. FIG. 3illustrates the baseplate 46 sutured the skin 62 at a tissue site 64.The distal end 14 of the device is adjacent a puncture in a vessel 66within the tissue site 64.

The pigtail 22 is positioned within the utility lumen 16 such that thepigtail extends through the distal end 14 of the device into the vessel66. A catheter 68 is threaded through the utility lumen 16 and thepigtail into the vessel 66. The catheter can be used to perform adesired medical procedure.

FIG. 4 illustrates the device after the catheter 68 and pigtail havebeen removed from the device. As illustrated, removing the catheter andpigtail leaves a puncture 70 in the vessel 66. Blood 72 from thepuncture pushes against the distal end 14 of the device. The backflowvalve 20 reduces the flow of blood from the vessel 66 into the utilitylumen 16.

In FIG. 5 a closure composition source 25 is coupled with the closurecomposition port 26. The closure composition 76 is delivered through theclosure lumen 24 to the reservoir adjacent the puncture 70. Energy canalso be delivered as illustrated by arrows 78. Any form of energy whichserves to raise the temperature adjacent the distal end 14 may be used.Examples of types of energy that may be used include RF, microwave,ultrasound, resistive heating, exothermic chemical heating,electromagnetic radiation, actinic radiation, laser, diffused laser,optical energy and frictional heating. The energy used is preferably RFenergy.

FIG. 6 illustrates the device and the vessel 66 after the partialremoval of the device from the tissue site 64. The closure compositionis delivered as the device is withdrawn to spread the closurecomposition along the length of the tissue site 64. As a result, closureof the tissues adjacent the puncture is also effected.

FIG. 7A illustrates a preferred embodiment of the distal end 14 of thedevice. As illustrated, the distal end 14 is saddle shaped 80 andsurrounds a portion of the vessel 66 circumference. Surrounding aportion of the vessel increases the area of contact between the vesseland the distal end of the device. This increased contact area enhancesthe stability of the distal end 14 relative to the vessel 66. As aresult, the opportunity for the distal end 14 to move between withdrawalof the catheter from the vessel and delivery of the closure compositionis reduced.

FIGS. 7B-7D illustrate an alternative embodiment of the saddle shaped 80distal end 14. The distal end 14 grips a portion of the vessel toenhance the stability of the distal end relative to the vessel.

FIGS. 8A and 8B illustrate an embodiment of a pigtail 22. The pigtail 22includes a tail portion 82 which is designed to rotate independently ofa head portion 84. The head portion 84 includes threads 86, a slot 88and a hole 90.

The tail portion 82 can be manufactured from any flexible andbiocompatible tubing, including, but not limited to, TEFLON tubing. Thehole in the head portion 84 is aligned with the tubing in the tailportion 82 so a catheter can pass longitudinally through the pigtail 22.The tail portion should be bent when the tail portion 82 is in a relaxedstate.

FIGS. 9A-9C illustrate a method of deploying the pigtail 22 within thedevice. To install the pigtail within the device an instrument 92 ispassed through the hole 90 and tail portion 82 of the pigtail 22. Theinstrument 92 is inserted into the utility lumen 16 and through thedistal end 14 of the device. The instrument is then pushed forward untilthe pigtail rests on a set of threads 94 in the device as illustrated inFIG. 9A. The device threads 94 are sufficiently short that the tailportion 82 of the pigtail is trapped in the backflow valve 20. Theinstrument 92 can be withdrawn from the pigtail 22. The installation ofthe pigtail 22 in the device can occur before or after the device hasbeen positioned within a tissue site 64.

In FIG. 9B, the instrument is withdrawn and a screwdriver 98 is insertedinto the slot 88 of the pigtail 22. The device threads 94 arecomplementary to the threads on the head portion 84 of the pigtail 22.Turning the screwdriver 98 can advance or withdraw the pigtail withinthe utility lumen 16. In FIG. 9C, the pigtail 22 has been advanced untilit is adjacent the backflow valve 20 and the screwdriver 98 has beenwithdrawn. The tail portion returns to its relaxed state after exitingthe backflow valve 20.

FIGS. 10-11 illustrate the closure of tissue as the device is withdrawnfrom the tissue site 64. In FIG. 10, a first closure composition hasbeen delivered to the reservoir and is accumulated against the puncture.A second closure composition source 100 is coupled with the secondclosure composition port 58. The second closure composition is deliveredthrough the second closure lumen 56 to the microporous membrane 54. Thesecond closure composition passes through the microporous membrane tothe tissue adjacent the lateral sides 12 of the device. Energy,indicated by the arrows 78 may also be delivered to the tissue site. Ina preferred embodiment, energy and the closure composition are deliveredin separate steps, optionally with the delivery of ultrasonic energyeither before during or after the delivery of energy and/or the closurecomposition.

The closure composition within the second closure composition source canbe the same as or different from the first closure composition. Forinstance, the first closure composition may be directed toward closureof the vessel while the second closure composition may be directed atclosure of the tissue adjacent the puncture.

The device may be retracted from the tissue site in a continuous motionor in a stepwise fashion. Energy can be delivered to the tissue sitebefore, after or simultaneously with delivery of closure composition.For example, a closure cycle may be used which involves (1) deliveringthe closure composition; (2) delivering energy; and (3) partiallyretracting the device. Other sequences for performing these three steps,including performing one or more of these steps at the same time isenvisioned and is intended to fall within the scope of the presentinvention. It is further noted that ultrasonic energy may be deliveredsimultaneously with any of these steps or in between any of these steps.FIG. 11 illustrates a tissue site after the device has been partiallyretracted. The closure composition delivered during the retractioncauses a tissue union 102.

FIGS. 12A and 12B illustrate an embodiment of the device and a method inwhich a solid or semi-solid closure composition positioned at the distalend 14 of the device can be used to facilitate closure of the vessel 66.In FIG. 12A the closure composition is positioned within the reservoir30 and is pushed aside when the pigtail 22 is delivered through thedevice. When the pigtail 22 is retracted, as illustrated in FIG. 12B,the closure composition is in position to be treated with energy toeffect the closure of the vessel 66. Although the solid or semisolidclosure composition is illustrated as being present at the device distalend 14, it should be noted that the solid or semi-solid closurecomposition may be used in combination with a fluid closure compositiondelivered through the device distal end 14. Optionally, the solid orsemisolid closure composition may be used independently of a fluidclosure composition.

A variety of sensors may be used in combination with the devices of thepresent invention. For example, temperature sensors may be used todetect the temperature adjacent the distal end 14 of the device. Atemperature sensor may also be use to detect the temperature adjacentthe sides of the device. These temperature sensors are useful forregulating the amount of energy being delivered to the vessel 66 andtissue adjacent the device. Suitable temperature sensors include, butare not limited to, thermocouples. The temperature sensors can haveseveral configurations including, but not limited to, rings which fitaround the body of the device or point senors distributed on the body ofthe device.

A pressure sensor may also be incorporated in the device, preferably atthe device distal end 14. The pressure sensor may be used, for example,to determine when the vessel 66 has been sealed, as signaled by areduction in pressure adjacent the device distal end 14.

Impedance sensors may also be employed when RF is used as the energy inorder to monitor the amount of energy being delivered to the tissue.

FIGS. 13-17 illustrate a method of using an embodiment of a device andits operation. In FIG. 13, a trocar 104 with a sharpened tip 106 isplaced within the utility lumen 16 of the device and is used to puncturethe skin 62, muscular tissue 108 and the vessel 66.

In FIG. 14 the trocar 104 is withdrawn and the backflow valve 20 isclosed to occlude the utility lumen 16. Closing the utility lumenreduces the loss of blood from the vessel through the utility lumen 16while exchanging the trocar 104 for another device to be positionedwithin the utility lumen. The flaps 110 generated in the artery by thepenetration of the trocar may partially close, but the degree of closureor whether the flaps of the artery close at all is not important to thefunction of this invention.

Referring to FIG. 15, a catheter guide obturator 112 is placed withinthe utility lumen 16 of the device and moved forward through thebackflow valve 20 to enter the vessel 66. The amount of forward movementof the device may be set (not shown) to a predetermined distance beyondthe distal end 14 of the device but since the distal end 14 of thecatheter guide obturator 112 has a rounded end, no damage to the vessel66 will occur if the catheter guide obturator 112 should contact the farwall of the vessel 66. The catheter guide obturator 112 has an internallumen 114 that is curved 116 near the distal end 14 to direct thecatheter 68 in the desired direction within the vessel 66. The backflowvalve 20 closes the gap between the outside diameter of the catheterguide obturator 112 and the utility lumen 16 of the device, reducingblood loss from the vessel. In this configuration, the procedurerequiring the catheter can be performed.

In FIG. 16, the catheter 68 and catheter guide obturator 112 arewithdrawn. A sealing mold 118 with a curing/ejection pin 120 ispositioned within the utility lumen 16 of the device. The position ofthe sealing mold 118 and curing/ejection pin 120 are set with a stopcollar 122 as it contacts an upper flange 124 of the device. A shallowcavity 126 is formed at the distal end 14 of the sealing mold 118. Thiscavity 126 is filled with a closure composition of the present inventionwhich is fed from a closure composition source 25 and passes through theclosure lumen 24 to fill the cavity 126. The filling of the cavity 126can be assisted by suction formed by pulling air through a port 128.This suction may additionally be used to assist in pulling the flaps 110of the vessel 66 upward against the distal end 14 of the sealing mold118.

The curing/ejection pin 120 may be constructed from an electricallyconductive material. Radio frequency energy passing through theelectrically conductive curing/ejection pin 120 to accelerate thepolymerization of the closure composition.

FIG. 17 illustrates a distal portion of an embodiment of a device. Thedevice includes a microporous membrane 54 applied to the outer diameterof the device. Side electrodes 32 are positioned at intervals along thelength of the body of the device. Alternatively the side electrodes canbe a single helix shaped electrode wound around length of the body (notshown). The side electrodes 32 can be positioned over the membrane 54 orbeneath the membrane 54 as illustrated. A second closure lumen 56 isincorporated into the device for delivering the closure composition tothe outer diameter of the device through the microporous membrane 54. Inthis regard, the closure composition should have a sufficiently lowviscosity to allow the composition to flow through the microporousmembrane 54 and against the tissue exposed to the device.

Upon completion of the curing/polymerization of the sealing plug 130,the closure composition will be injected through the second closurelumen 56 and Radio frequency energy will be applied to the annularelectrodes 32. The closure composition is preferably of a nature thatallows electrical current to flow through the closure composition toenable heating of the composition by the energy being delivered. After atarget temperature has been reached, the device is withdrawn. Uponwithdrawal, the walls of the tissue site 64 can close in againstthemselves, the bonding action of the composition will cause adhesionand sealing of the tissue. Additionally, the action of the energy (forexample RF energy) on the tissue for the appropriate amount of time andat the proper temperature can promote coagulation. The combination ofthese factors can provide rapid sealing of the tissue site 64.

A suitable backflow valve 20 is a flapper valve as illustrated in FIG.18. The flapper valve is preferably formed of an elastomeric materialsuch as medical grade silicone rubber. The configuration, as illustratedby the cross sectional view, may be a cylindrical section transitioninginto a conical portion. The conical portion has a series of slits 132which allow various implements to pass through the valve. The thicknessof the flaps 134 and the flexibility of the elastomeric material will bebalanced to provide memory sufficient to close the opening as theimplements are withdrawn and provide a fluid seal. Blood pressureagainst the outer surface of the cone will cause the flapper valve toclose more tightly.

FIG. 19 illustrates yet another embodiment of the present invention. Aremovable trocar 104 is temporarily positioned in the utility lumen ofthe device. The trocar has a pointed tip which can be used forpuncturing the skin, tissue and blood vessel to allow the placement ofthe device into the tissue and into a femoral artery. Closurecomposition port 26 provides a channel through which the closurecomposition may be introduced through a closure lumen (not shown) tomicroporous membrane 54. The closure lumen allows the closurecomposition to pass through the microporous membrane 54 into the tissue.As illustrated, segments of the microporous membrane 54 are separated byside electrodes 32, the controls attachment port 40 being for RF energy.It should be noted, however, that the device may be adapted for deliveryof other forms of energy as described above.

The temperature sensors 36 are used to sense the temperature adjacentthe distal end 14. The temperature feedback may be pre-set as well asadjusted during use.

In the embodiment illustrated, temperature sensors are operativelycoupled with an automated device withdrawal system 136. The temperaturesensors can activate springs 138 within a rack 140 coupled with the mainmember 142. The activation of the springs causes the device to bewithdrawn from the tissue site. As a result, withdrawal of the devicecan be correlated with the temperatures at various zones 144 within thetissue site. For example, as zone one reaches a specific pre-determinedtemperature, the springs become activated and the rack 140 partiallywithdraws the device. As each subsequent zone meets a pre-determinetemperature, the device is withdrawn further. Suitable pre-determinedtemperatures include, but are not limited to, 45-50° C. This withdrawalsequence can be repeated until the device is withdrawn through zonesfive, four, three, two, and one. Closure composition can be deliveredbefore after and during the withdrawal of the device. As a result, thedevice leaves the vessel sealed and the tissue welded together as thedevice is withdrawn.

FIGS. 20-22 illustrates the use of the device of FIG. 19 where thevessel 66 is a femoral artery. FIG. 20 illustrates a plurality ofsutures holding the device in position at a tissue site. FIG. 21 showsthe catheter introduced into the femoral artery for performance of asurgical procedure.

FIG. 22 shows the withdrawal of the catheter and the device. Duringwithdrawal of the device, closure composition is delivered to the tissuesite 64 through the microporous membrane and RF energy is applied. Asthe temperature elevates and the closure composition infused, thetemperature sensor 36 indicates to the spring system that the deviceshould start to back away. As it backs away, it seals the tissue throughelevated temperature, saline, and collagen infusion, achieving acapillary flow and molecular bonding. The whole area is sealed as thedevice is retracted. The device is then removed, and a plaster isapplied to the wound.

FIGS. 23A-23C illustrate another embodiment of the present invention.The body 10 includes a central lumen 16 and a bloodspurt lumen 146. Ablood spurt port 148 with a shutoff valve 150 opens into the bloodspurtlumen 146 and a closure composition port 26 opens into the utility lumen16. At the proximal end of the body is a stop collar 152 configured toaccommodate the proximal end of an obturator. A catch channel 154 ispositioned within the proximal end of the body 10. A first closure lumen156 has a closure composition port 26 through which one or more fluentclosure compositions can be delivered into the closure lumen. The firstclosure lumen includes an exit port 158 through which the one or morefluent closure composition precursors can be delivered from the firstclosure lumen to the utility lumen 16.

FIGS. 24A and 24B illustrate an obturator 160 for use with the body 10of FIGS. 25A and 25B. The obturator 160 includes an obturator body 162with a distal end 164 and a proximal end 166 with an enlarged head 168.A spring biased obturator knob 170 is positioned at the proximal end166. The obturator knob 170 is coupled to an internal latch 172. Thelatch includes a catch 174 which extends through an opening 176 in theobturator body 162. Turning the obturator knob 170 causes the catch 174to withdraw through the obturator body 162. The obturator body 162further includes a distal electrode 178 and side electrodes 180. Atemperature sensor 36 such as a thermocouple 36 is secured within thedistal electrode 178 by potting composition. An additional temperaturesensor 36 is coupled to the inner surface of the side electrode 180.Radiofrequency conductors and thermocouple wires feed through theinternal diameter of the obturator body 162 in a connector cable 182.

FIGS. 25A and 25B illustrate the obturator 160 disposed within thedevice body 10. In FIG. 25A the enlarged head 168 of the obturator 160contacts the stop collar 152 and prevents the obturator from slidingfurther into the device body. The external diameter of the obturator 160is smaller than the diameter of the utility lumen 16. As a result, theobturator 160 partially defines a second closure lumen 184 between theobturator and the elongated body. The second closure lumen is coupledwith the first closure lumen and is configured to receive closurecomposition delivered through the first closure lumen. The obturator canbe withdrawn relative to the device along arrows 186 until the catch 174engages the catch channel 154 as illustrated in FIG. 27B.

FIGS. 26-34 illustrate operation of the device of FIG. 23. Asillustrated in FIG. 26, a hollow needle 188 is inserted through thetissue site 64 until the vessel 66 is punctured. Location of the needle188 within the vessel 66 is confirmed by a blood spurt 190 from theproximal end 192 of the needle 188.

In FIG. 27A a guidewire 194 is fed through the needle 188 into thevessel 66. In FIG. 27B the needle 188 is withdrawn along the guidewire194 leaving the guidewire 194 in place. In FIG. 28, a hollow dilator 196is placed in the utility lumen 16 of the device.

In FIG. 29, the guidewire 194 is threaded though the dilator 196 whichis pushed forward along the guidewire 194 into the tissue site 64 todilate the puncture 70. The advancement of the device is stopped oncethe distal end 14 is within the vessel 66 as indicated by a bloodspurtfrom the bloodspurt lumen 146.

In FIG. 30, the dilator 196 and guidewire 194 are withdrawn from thelumen 16. The device is withdrawn in the direction of the arrow 198until the distal end 14 is positioned outside the vessel 66 adjacent thepuncture 70. The position of the distal end 14 outside the vessel 66 isindicated when the bloodspurt ceases. At this stage, a catheter or otherdevice can be fed through the utility lumen and surgical proceduresperformed. Upon completion of the procedure, the catheter and sheath areremoved from the device. A backflow valve 20 can be included at thedistal end 14 to reduce blood loss.

In FIG. 31, the obturator 160 is placed in the utility lumen 16 untilthe enlarged head 168 of the obturator 160 contacts the stop collar 152of the device. The obturator has a length such that when the enlargedhead of the obturator 160 contacts the stop collar, the distal end 164of the obturator 160 extends slightly beyond the distal end 14 of thedevice or is flush with the distal end 14 of the device as illustrated.Since the distal end 14 of the device is positioned outside the vessel66 adjacent the puncture 70, the distal end 164 of the obturator ispositioned outside the vessel 66 adjacent the puncture 70.

In FIG. 32 RF energy is applied from the distal electrode 178. Theenergy coagulates the blood and protein near the puncture 70.Additionally, a closure composition source 25 can be coupled to theclosure composition port 26 and closure composition applied. The energyand closure composition create a first seal 200 at the puncture 70.

The obturator 160 is withdrawn form the device until the catch 174engages the catch channel 154. As illustrated in FIG. 33, a gap 202 isformed between the distal end 164 of the obturator 160 and the firstseal 200. A closure composition source 25 is coupled to the closurecomposition port 26 and closure composition 76 applied. The closurecomposition flows through the closure lumen and fills in the gap 202.Radiofrequency energy can be applied from the distal electrode 178 toaccelerate the polymerization of the closure composition. FIG. 34illustrated the tissue site 64 after the device is completely withdrawn.Pressure is applied at the arrows 204 to encourage curing of the closurecomposition and reduce bleeding in the tissue site 64.

The closure composition can be a fluent material that can behydraulically translated from a reservoir through the closure lumen.When a microporous porous membrane is used, the viscosity of the closurecomposition should be sufficiently low that the composition can exitthrough pores of a microporous membrane at a reasonable rate, preferablyat least about 1 mL per minute. The viscosity of the composition shouldalso be sufficiently high that the composition will remain in thevicinity of the area to be treated with the composition for a sufficientamount of time for energy to be delivered to the composition. Energy ispreferably applied for from 0.1 sec to 600 sec, more preferably forabout 1 sec to about 20 sec. Accordingly, the composition should besufficiently viscous to remain adjacent the device for these periods oftime. In one embodiment, the viscosity of the fluent closure compositionis between 1 cps and about 10,000 cps, preferably from about 20 cps toabout 5,0000 cps.

Suitable closure compositions include, but are not limited to, closurecompositions composed of three components, a matrix component, aconductivity enhancer, and a composition vehicle. Fluent closurecompositions may be a homogenous solution, a slurry, a suspension, anemulsion, a colloid hydrocolloid, or a homogeneous mixture.

The matrix forming component may be any biocompatible material which canform a matrix for facilitating wound closure and sealing upon theapplication of a threshold energy. Examples of suitable classes ofmatrix forming components include proteins, glycoproteins,protoeglycans, mucosaccharides and blycoaminoglycans. The matrix formingcomponent may include ionizable functional groups such as carboxylicacid residues, protonated amino groups, etc., that increase thecompatibility of the matrix forming component with water-based vehiclesolvents. The matrix forming material may also include chemicalfunctionalities that are reactive with themselves and each other when athreshold energy is applied. Ultimately, thermal or light energy willspeed these so-called cross-linking” reactions within the matrixcomponent and between the matrix component and tissue surfaces. Examplesof such reaction chemical functionalities are carboxy groups, aminogroups, thiol groups, disulfide groups, hydroxy groups, ester groups,and amide groups.

When the energy source 42 used to effect the closure is RF energy, theelectrical conductivity of the fluent closure composition is preferablysuch that the impedance is below 200 ohms, more preferably, below 10ohms. Because of its innate conductivity, water is the preferred basevehicle for the closure composition. Additionally, many ionicconductivity enhancers are available to allow adjustment of the overallimpedance of the fluent closure composition.

In one embodiment the vehicle is physiologic saline solution. Inprinciple, an aqueous vehicle may benefit from this inclusion of aconductivity enhancer; preferred enhancers are those that occurnaturally in the body, such as sodium chloride, various phosphate salts,salts of simple amino acids such as aspartic acid or glutamic acid,calcium chloride, etc. The conductivity enhancer may also function as aphysiologic buffer to minimize acid or alkaline effects. The componentsmay be a mixture of sodium and potassium salts at levels to mimic thosetypically found in the body.

The liquid vehicle is preferably water. Relatively inert viscositymodifiers may be included, such as polysaccharides, poly(alkyleneoxides), and material gums such as camageenan and xanthan gum. viscositymodifier selection and level are controlled so as not to detrimentallyaffect the overall conductivity of the fluent closure composition if RFenergy is used.

Listed in Table 1 are examples of matrix components that may beemployed. Listed in Table 2 are examples of conductivity enhancers thatmay be employed. Listed in Table 3 are examples of composition vehiclesthat may be employed.

Table 1 Matrix Components

Proteins

collagen, albumin, elastin, fibrin, laminin, algin, gelatin, fibronectin

polypeptides, e.g. glutathione

Saccharides

polysaccharides, oligosaccharides, monosaccharides

starch and derivatives, e.g. amylose, amylopectin, dextrin

carbohydrate materials (aldo- and keto-derivatives of saccharides)

Muco-polysaccharides

N-hetero saccharides (polymeric, oligomeric and monomeric), preferablyhexosamine derivatives

N-substituted saccharide derivatives (polymeric, oligomeric andmonomeric), preferably N-acetyl derivatives

O-substituted saccharide derivatives, polymeric and oligomeric,preferably O-sulfato derivatives (—O—SO₃H functionality), e.g.,chrondoin B sulfate, a hexosamine derivative which has bothN-acetylation and O-sulfonation

Glycosaminoglycans (GAG's, linear N-hetero polysaccharides; e.g.,heparin, heparan sulfate, keratosulfate, dermatan, hyaluronic acid,agarose (galactan), carrageenan)

Mucoproteins and Proteoglycans

hexosamine-protein and saccharide-hexosamine-protein conjugates

chemically modified proteins, saccharides, GAG's and mucopolysaccharides

derivatives prepared by acetylation, alkylation or sulfonation ofhydroxyl, amino or carboxy functional sites, such a acetylated orsulfonated collagen

derivatives prepared by thionylation (introducing —SO₂—), sulfurization(S—), or disulfide (—SS—) coupling

Synthetic Polymer Conjugates

synthetic functional polymers covalently bonded to proteins, saccharidesand muco-polysaccharides either by direct interaction,prefunctionalization of either synthetic polymer or natural material orby use of a coupling agent to bond the synthetic polymer and protein,saccharide, GAG or muco-polysaccharide together. Examples of syntheticpolymers include poly(alkylene oxides, such as poly(ethylene oxide)(PEO), polycaprolactones, polyanhydrides, polyorthocarbonates,polyglycolides, polylactides, polydioxanones or co-polymers thereof.Examples of conjugates are collagen-PEO and heparin-PEO.

Table 2 Conductivity Enhancing Materials

Inorganic ionic salts

Cationic component: derived from alkaline and alkaline earth elements,preferred cation is sodium, Na⁺

Anionic component: halide, preferably chloride, phosphate (—O—PO₃ ⁻³,—O—PO₄H⁻², —O—PO₄H₂ ⁻¹), carbonate, bicarbonate

Organic Ionic Salts

Cationic component: ammonium, derived from protonation of lysine orarginine residues

Anionic component: carboxylate, e.g. asparate or glutamate, O-phosphateester (—O—PO₃ ⁻³, —O—PO₄H⁻², —O—PO₄H₂ ⁻¹), (glucose-1-phosphate,glucose-6-phosphate, polysaccharide phosphates and polyphosphates),O-sulfate ester (e.g., glycasoaminoglycan sulfates, such as heparansulfate, chrondoin sulfate)

Table 3 Composition Vehicles

Water

Water-poly(alkylene oxide) mixtures, e.g. water-poly(ethylene oxide)mixtures =p While the present invention is disclosed by reference to thepreferred embodiments and examples detailed above, it is to beunderstood that these examples are intended in an illustrative ratherthan limiting sense, as it is contemplated that modifications willreadily occur to those skilled in the art, which modifications will bewithin the spirit of the invention and the scope of the appended claims.

1. A method for introducing a catheter through a puncture within avessel and sealing the puncture, comprising: providing an apparatuscomprising an elongated body having a distal end, the body including acircumferential wall having an inner surface and an outer surface, thebody further including a utility lumen defined by the inner surface ofthe circumferential wall and a closure lumen separate from the utilitylumen and being defined by a bore within the circumferential wallbetween the inner and outer surfaces, the closure lumen having a fluiddelivery port located at a fixed distance from the distal end of theapparatus, positioning the elongated body within the tissue site,delivering a catheter through the utility lumen into the vessel,performing a treatment with the catheter, withdrawing the catheterthrough the utility lumen, and delivering a closure composition throughthe closure lumen to the puncture.
 2. The method of claim 1, furthercomprising: delivering energy from at least one electrode on theelongated body to the closure composition delivered to the puncture. 3.The method of claim 1 wherein the elongated body includes a membranepositioned on the elongated body to be adjacent to a portion of tissueadjacent the puncture when the elongated body is positioned within thetissue site, and a second closure lumen through which a second closurecomposition can be delivered to the membrane.
 4. The method of claim 3,further comprising: delivering the second closure composition throughthe second closure lumen to the membrane such that the second closurecompound is delivered through the membrane to contact a portion of thetissue site adjacent the puncture.
 5. The method of claim 4, furthercomprising: delivering energy from at least one electrode on theelongated body to the second closure composition which has beendelivered to the tissue site.